Search Results

For immediate load use, without an abutment, in either partially or fully edentulous mandibles and maxillae, for fixed or detachable prosthesis and for use in support of free-standing restorations with or without the involvement of adjacent dentition.

The product is an endosseous dental implant for prosthetic attachment; trade name: Sargon Immediate Load Implant™. It is substantially equivalent to previously marketed models of this device described in premarket notifications K930071 and K961005. In this design, the collar is longer and allows the direct fixation of a prosthesis to the implant with or without the use of an abutment. The material is the same as the predicate devices; i.e., titanium alloy conforming to ASTM standard F136 "Standard Specification for Wrought Titanium 6Al-4V Ell Alloy for surgical Implant Applications."

The provided text describes a 510(k) summary for the Sargon Immediate Load Implant, but it does not contain information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.

The document is a regulatory submission for a dental implant, focusing on its substantial equivalence to previously marketed devices. It details the device's material, indications for use, and confirms FDA clearance. Regulatory letters and forms are included, but there is no technical study data or performance metrics.

Therefore, I cannot provide the requested information based on the given input.

Ask a specific question about this device